Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Ibuprofen 600 mg ER; Drug: Placebo

• Registration Number: NCT01266161
• Lead Sponsor: Pfizer

Brief Summary

The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-22
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-24
• Primary Completion: 2011-03-31
• Study Completion: 2011-03-31
• Disposition First Submitted: 2012-04-19
• Disposition First Submitted QC: 2012-04-19
• Disposition First Posted: 2012-04-24
• Results First Submitted: 2013-02-20
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Results First Posted: 2018-08-15
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Males and females 16 to 40 years of age
• Subjects who undergo surgical removal of at least two third molars
• One of which must be a partial or full bony mandibular impaction
• Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)

Exclusion Criteria

• Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
• Presence or history of any significant organ disease
• Use of prescription or OTC first generation antihistamines
• Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen 600 mg extended release	Ibuprofen 600 mg ER	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)	Baseline to 12 hours	SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \[=\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.
Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose	8 to 12 hours	SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy.

Secondary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Relief Scores (TOTPAR)	0-12 hours, 8-12 hours	TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best).
Time-weighted Sum of Pain Intensity Difference (SPID) Scores	0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours	SPID is a derived endpoint from PID scores. For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity.
Percentage of Participants Taking Rescue Medication	Baseline to 48 hours	Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval.
Pain Relief (PR) Scores	0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours	A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: "How much relief do you have from your starting pain?" Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief.
Pain Intensity Difference (PID) Scores	0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours	For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity).
Time to First Dose of Rescue Medication After First Dose of Study Drug	Baseline to 12 hours	During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded.
Time to Confirmed First Perceptible Relief	Baseline to 12 hours	The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling.
Pain Relief Combined With Pain Intensity (PRID) Scores	0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours	PRID score=PR plus PID. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity.
Number of Doses of Rescue Medication Used	0-12, 12-24, 24-36, 36-48, 0-48 hours
Time to Meaningful Relief	Baseline to 12 hours	Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant.
Participant Global Evaluation Score	24 and 48 hours	Participants responded, on a 6-point categorical scale, to the following question: "How would you rate this medication as a pain-reliever?" Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.

Trial Locations

Locations (2)

Premier Research; 🇺🇸 Austin, Texas, United States

Central Texas Oral Surgery Associates; 🇺🇸 Austin, Texas, United States